March 8, 2003
WASHINGTON -- Millions of users of St. John's wort, calcium and other dietary supplements may soon know for sure they're getting what they pay for: The government proposed the first manufacturing standards for the $19-billion supplement industry Friday in an attempt to cut fraud and contamination.
There will be no guarantee that the pills and powders deliver the health benefits advertised or are even safe to swallow. Unlike drugs, supplements can be sold without any scientific proof of safety or effectiveness.
But the Food and Drug Administration's long-awaited factory rules aim to ensure that the ingredients and dosages promised on a supplement's bottle really are inside -- without dangerous contaminants like bacteria and brain-damaging lead that have been found in some.
"Millions of Americans use dietary supplements every day, and we need to make sure they're getting the products they pay for . . . that are accurately labeled and free from contaminants," FDA Commissioner Mark McClellan said.
There are more than 1,000 makers of dietary supplements, products that range from mainstream vitamins to herbs to controversial hormones and stimulants. Ephedra, an herbal stimulant blamed for dozens of heart attacks, strokes and deaths, is the most notorious, drawing an FDA warning last week.
Supplement makers are exempt from most safety oversight, thanks to a 1994 law. Nor has there even been federal quality control: Over and over in recent years, scientists and consumer groups have uncovered fraud when testing various types and brands.
The FDA cited a bee product found to be contaminated with lead, and a brand of folic acid, required during pregnancy to reduce birth defects, that contained only a third of the promised dose.
The new manufacturing standards aim to prevent such problems with certain quality-control steps that require company testing of ingredients and finished products to verify purity and dose. Also required would be improvements in labeling and ways to handle consumer complaints.
The rules are open for public comment for three months. Final regulations are expected next year, and manufacturers then would have time to start complying: up to three years for the smallest companies. McClellan promised inspections of supplement factories, with special focus on "potential bad actors."